MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Model Number	1012630-39
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not be returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed emergently, treating right leg pain.The target lesion was in the right iliac artery, via left common femoral access.The omnilink elite stent delivery system was advanced, but was unable to traverse the bifurcation, due to severe calcification.The decision was made to try access via the right common femoral artery; however, the device was still unable to cross.Access then attempted via the right radial artery.The target lesion was ballooned with an unspecified dilatation catheter and the omnilink was advanced; however, the device was still unable to cross the target lesion.Only the front portion of the omnilink was able to cross.The decision made to advance a non-abbott sheath; however, the sheath became caught on the proximal edge of the stent.The physician tried to pull the stent delivery system into the sheath; however, the stent dislodged and embolized to the right common femoral artery.An attempt was made to snare the dislodged stent; but this was not possible.The stent remained in the common femoral artery and a cut-down procedure was performed.The stent was able to be removed.A patch was placed on the right common femoral artery.The patient is being evaluated for endarterectomy, but is in stable condition.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The reported patient effects of embolism and surgical intervention are listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use (ifu) as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties and subsequent treatments, including removal of foreign body, appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15272334
• Report Number: 2024168-2022-09044
• Device Sequence Number: 14929046
• Product Code: NIO
• UDI-Device Identifier: 08717648178474
• UDI-Public: 08717648178474
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1012630-39
• Device Catalogue Number: 1012630-39
• Device Lot Number: 0032541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female